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Clinical Research Methodology

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Clinical Research Methodology
Aims and Objectives ,[object Object],[object Object],[object Object]
Clinical Research/Epidemiology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Steps in Clinical Research ,[object Object],[object Object],[object Object],[object Object],[object Object]
Cross-sectional study ,[object Object],[object Object],[object Object]
Cross-sectional study ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Steps in Clinical Research ,[object Object],[object Object],[object Object],[object Object],[object Object]
Association and Causation ,[object Object],[object Object],[object Object],[object Object]
Explanations for a Positive Association ,[object Object],[object Object],[object Object],[object Object],[object Object]
Bias ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Selection Bias ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Selection Bias - example ,[object Object],[object Object],[object Object]
Information Bias ,[object Object],[object Object],[object Object]
Information Bias – Observer Bias ,[object Object],[object Object],[object Object],[object Object]
Information Bias - Recall Bias ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Confounding ,[object Object],A C B
Features of Confounding ,[object Object],[object Object],[object Object],[object Object]
Remedies to Confounding ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Case Control Study ,[object Object],[object Object],[object Object],[object Object]
Case Control Study ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Cohort Study ,[object Object],[object Object],[object Object],[object Object]
Steps in Clinical Research ,[object Object],[object Object],[object Object],[object Object],[object Object]
Intervention and Evaluation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Steps in Designing Clinical Trial ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Rationale for Trial ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Rationale for Trial ,[object Object],[object Object],[object Object],[object Object],[object Object]
Rationale for trial ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Examples in Rheumatoid Arthritis ,[object Object],[object Object],[object Object]
Hypothesis ,[object Object],[object Object],[object Object],[object Object]
An Example In RA Does adding monthly IM depot steroids to conventional slow-acting drugs reduce the number of patients developing new erosions?
Type of Trial ,[object Object],[object Object],[object Object],[object Object]
Parallel Groups Cases Randomised Treatment O Treatment A Cases Randomised Treatment O Treatment A Treatment B
Factorial design Cases Randomised O A B A+B
Cross-over Design Cases Randomised O A A O
Selecting Cases (a) ,[object Object],[object Object],[object Object],[object Object]
Select cases (b) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Selecting cases (c) Hard Inclusion Criteria Soft Inclusion Criteria Less chance of response Good generalisability Rapid entry Good chance response Poor generalisability Long period of entry
Randomised Controlled Trials (RCT) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Outcome measures ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Core Data In RA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Physician And Patient Assessments
Clinical Outcomes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Number of Cases: Sample Size ,[object Object],[object Object],[object Object]
Controls and Blinding ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Significance and Power ,[object Object],[object Object]
Analysis (a) ,[object Object],[object Object],[object Object],[object Object]
Analysis (b) Potential cases Did not fulfil entry criteria Given information Did not consent Randomised Early withdrawal Adverse effect Lack of effect Inter-current illness Other Completed study
Analysis (c) ,[object Object],[object Object]

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Clinical Research Methodology

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  • 30. An Example In RA Does adding monthly IM depot steroids to conventional slow-acting drugs reduce the number of patients developing new erosions?
  • 31.
  • 32. Parallel Groups Cases Randomised Treatment O Treatment A Cases Randomised Treatment O Treatment A Treatment B
  • 33. Factorial design Cases Randomised O A B A+B
  • 34. Cross-over Design Cases Randomised O A A O
  • 35.
  • 36.
  • 37. Selecting cases (c) Hard Inclusion Criteria Soft Inclusion Criteria Less chance of response Good generalisability Rapid entry Good chance response Poor generalisability Long period of entry
  • 38.
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  • 40.
  • 41. Physician And Patient Assessments
  • 42.
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  • 46.
  • 47. Analysis (b) Potential cases Did not fulfil entry criteria Given information Did not consent Randomised Early withdrawal Adverse effect Lack of effect Inter-current illness Other Completed study
  • 48.